A composition for preventing and treating osteoporosis, a preparation method thereof, and an application thereof

Abstract

The application discloses a composition for preventing and treating osteoporosis and a preparation method and application thereof, and belongs to the field of biopharmacy. The method comprises the following steps: uniformly spraying a sodium bicarbonate aqueous solution on eucommia ulmoides oliver powder, sealing and infiltrating, and then slowly frying, spraying vinegar in the frying process, turning off the fire after the silk is broken, and then spreading and airing to reduce the temperature, and then extracting by ethanol reflux to obtain eucommia ulmoides oliver extract; sterilizing the drynaria rhizome powder at high temperature, adding lactobacillus plantarum after cooling, sealing and fermenting, and then extracting by ethanol reflux to obtain drynaria rhizome extract; and uniformly mixing the extracted eucommia ulmoides oliver extract and the drynaria rhizome extract, D-glucosamine hydrochloride, sodium chondroitin sulfate, epimedium extract and oyster powder to obtain the composition for preventing and treating osteoporosis. The eucommia ulmoides oliver is prepared by the method of sodium bicarbonate salt stir-frying and vinegar stir-frying, and the drynaria rhizome is treated by fermentation, so that the warm and dry properties of the original composition can be neutralized, the side effects of heatiness such as constipation, dry mouth, gum swelling and pain or sore throat can be reduced, and the safety and tolerance of the composition are improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of biopharmacy, in particular to a composition for preventing and treating osteoporosis and a preparation method and application thereof. BACKGROUND

[0002] Osteoporosis is a systemic metabolic bone disease characterized by bone mass reduction, bone tissue microstructure destruction, bone fragility increase and easy fracture. The disease can occur in different genders and at any age, but is more common in postmenopausal women and elderly men. The clinical manifestations are bone fragility, easy fracture, possible lumbar and back pain, height shortening and humpbacked symptoms.

[0003] With the aggravation of population aging, the incidence of osteoporosis continues to rise, which has become an important reason affecting the quality of life of the middle-aged and elderly. At present, the western medicine for treating the disease mainly includes estrogen, calcium agent, calcitonin, bisphosphonate and fluorine preparation, etc. These drugs generally have the problem of high price, and long-term use also shows obvious side effects.

[0004] In the prior art, there are drug compositions for improving osteoporosis by adding natural drugs. For example, the prior art CN106165898A discloses a health care composition with the functions of increasing bone density and freeing joints and a preparation method. The health care composition is made of the following raw materials: chondroitin sulfate, glucosamine, hyaluronic acid, paecilomyces hepiali mycelium, eucommia ulmoides, radix cyathulae, epimedium, smilax glabra, dendrobium and drynaria. The composition is used to supplement kidney and strengthen bones and free joints simultaneously, and has the functions of increasing bone density and freeing joints by synergistic effect, and has the effect of preventing and improving osteoporosis. However, long-term use in the clinic shows that it is easy to cause constipation, gum swelling and pain, sore throat and other symptoms of internal heat. Especially for the elderly and people with yin deficiency and excessive heat, it is more likely to cause constipation, defecation difficulty and other side effects.

[0005] The reason may be that eucommia ulmoides is warm and sweet, and excessive consumption may aggravate the dry heat in the body, causing symptoms such as dry mouth and throat, sore throat, constipation, restlessness and insomnia; epimedium is warm, and long-term or large-dose consumption may cause excessive yang in the body, causing symptoms such as dry mouth and constipation; drynaria is bitter and warm, and long-term or excessive consumption may consume the body's yin fluid, causing constipation due to lack of intestinal moisture; calcium agent may combine with oxalic acid and phosphoric acid to form insoluble calcium salt, absorbing intestinal water and making the feces hard. The combined use of these three traditional Chinese medicines and calcium agent may further reduce the intestinal water and aggravate the side effects of constipation.

[0006] Therefore, it is urgent to develop a new composition for preventing and treating osteoporosis which can effectively prevent and treat osteoporosis and avoid adverse reactions such as constipation, so as to improve the safety and tolerability of long-term medication of patients and improve the patient compliance. SUMMARY

[0007] The technical problem solved by the present application is to provide a preparation method of an osteoporosis-preventing and treating composition, which improves the extraction method of raw materials in the composition, so that the composition can prevent and treat osteoporosis while avoiding adverse reactions such as constipation, thereby improving the safety and tolerance of long-term medication of patients, improving patient compliance, and overcoming the problem of obvious side effects of the existing osteoporosis-preventing and treating composition.

[0008] To solve the above technical problem, the present application provides a preparation method of an osteoporosis-preventing and treating composition, comprising the following steps:

[0009] (1) Preparing eucommia extract: uniformly spraying sodium bicarbonate aqueous solution onto eucommia powder, stirring, and then sealing and soaking for 1 h, and uniformly spraying rice vinegar at 60-80°C during the process of frying at low heat at 100-120°C, and then turning off the heat after frying to broken silk, and airing and cooling, and then using 70% ethanol to reflux extract the eucommia after cooling for 2 times, filtering, and then concentrating and drying the supernatant to obtain eucommia extract;

[0010] (2) Preparing rhizoma drynaria extract: adding rhizoma drynaria powder into a fermentation tank, adding water, sterilizing at high temperature, and then adding lactobacillus plantarum after cooling, uniformly mixing, and then sealing and fermenting at 35°C for 3 days, and then using 75% ethanol to reflux extract the rhizoma drynaria for 2 times, filtering, and then concentrating and drying the supernatant to obtain rhizoma drynaria extract;

[0011] (3) Preparing the composition: uniformly mixing 75-85 g of the eucommia extract prepared in step (1), 50-60 g of the rhizoma drynaria extract prepared in step (2), 140-180 g of D-glucosamine hydrochloride, 60-100 g of chondroitin sulfate sodium, 50 g of epimedium extract, and 55 g of oyster shell powder, to obtain the osteoporosis-preventing and treating composition.

[0012] Further improvement, the eucommia powder in step (1) is passed through a 20-mesh sieve, the sodium bicarbonate in the sodium bicarbonate aqueous solution is used in an amount of 2% of the weight of the eucommia powder, the volume of the rice vinegar sprayed is 0.2 ml / g of the weight of the eucommia powder, the concentration of acetic acid in the rice vinegar is 9%, and the frying time at low heat is 8-10 min.

[0013] Further improvement, the rhizoma drynaria powder in step (2) is passed through an 80-mesh sieve, the volume of the water added is 0.4 ml / g of the weight of the rhizoma drynaria powder, the high-temperature sterilization condition is heating at 100°C for 20 min, the lactobacillus plantarum is lactobacillus plantarum ATCC 8014, and the number of live bacteria of the lactobacillus plantarum added is 8×10 8 ~ 1×10 9 CFU / ml.

[0014] Further improvement, the step (3) is prepared by the following steps: weighing the extract of eucommia ulmoides obtained in step (1) 80g, the extract of rhizoma drynariae obtained in step (2) 55g, D-glucosamine hydrochloride 160g, chondroitin sulfate sodium 80g, epimedium extract 50g and oyster shell powder 55g, and mixing uniformly, thereby obtaining the composition for preventing and treating osteoporosis.

[0015] In the above preparation method, the aqueous solution of sodium bicarbonate is sprayed on the surface of eucommia ulmoides powder before frying, so that the permeability of the plant cells is changed and the permeability of sodium bicarbonate is improved. The alkalinity of sodium bicarbonate can destroy the hydrogen bond structure of the gum silk and reduce its viscosity. At the same time, in the process of sodium bicarbonate salt frying of eucommia ulmoides, rice vinegar with a temperature of 60-80 DEG C is sprayed, and CO2 gas is generated by the reaction of rice vinegar and sodium bicarbonate permeated into the eucommia ulmoides gum during frying. The tiny bubbles play a physical destruction role on the eucommia ulmoides gum with intestinal viscosity, thereby improving the dissolution of the active ingredients. The rice vinegar can also reduce the astringency of alkaloids and tannins and reduce the intestinal viscosity. The preparation method uses sodium bicarbonate salt frying and vinegar frying to reduce the breaking temperature of eucommia ulmoides gum silk, reduce the processing time from 20-30 min to 8-10 min, avoid the loss of heat-sensitive active ingredients, reduce energy consumption, and improve the content of active ingredients. Moreover, rapid airing and cooling after sodium bicarbonate salt frying and vinegar frying can further avoid the loss of heat-sensitive ingredients and the re-aggregation of gum silk. The sodium bicarbonate salt frying and vinegar frying processing method can moderate the eucommia ulmoides warm dryness, help to reduce the warm dryness, reduce the risk of heatiness, and is more suitable for people with yin deficiency, which can reduce the symptoms of heatiness such as dry mouth and throat, sore throat, constipation, irritability and insomnia.

[0016] In the preparation method, the plant lactobacillus fermentation of rhizoma drynariae can secrete carbohydrate hydrolase to decompose naringin in rhizoma drynariae into naringenin, reduce the astringency, promote intestinal peristalsis, and significantly reduce the risk of constipation, thereby improving the patient's compliance.

[0017] In the preparation method, the content of icariin in epimedium extract is 2.5%.

[0018] The application also provides a composition for preventing and treating osteoporosis, which is prepared by the above-mentioned preparation method of the composition for preventing and treating osteoporosis.

[0019] The present application also provides an oral preparation for preventing and treating osteoporosis, which comprises the above-mentioned composition for preventing and treating osteoporosis and pharmaceutically acceptable adjuvants.

[0020] The oral preparation is a tablet, granule or capsule.

[0021] The oral preparation is a tablet, and the preparation method comprises the following steps: weighing 80 g of the Eucommia ulmoides Oliv. extract and 55 g of the Drynaria fortunei extract, adding 160 g of D-glucosamine hydrochloride, 80 g of chondroitin sulfate sodium, 50 g of the Epimedium brevicornum Maxim. extract, 55 g of oyster shell powder and 115 g of microcrystalline cellulose, uniformly mixing, preparing soft material by using 95% ethanol, granulating by using an 18-mesh sieve, drying at 55-60 DEG C, rounding the granules by using a 16-mesh sieve, adding 5 g of magnesium stearate, mixing for 30 min, and then pressing the mixture to obtain the tablet of the composition for preventing and treating osteoporosis.

[0022] The present application also provides the use of the above-mentioned composition for preventing and treating osteoporosis in the preparation of a medicine for preventing and treating osteoporosis.

[0023] In the above-mentioned use, the composition can reduce the side effects of internal heat, such as constipation, dry mouth, gum swelling and pain or sore throat, caused in the process of preventing and treating osteoporosis.

[0024] After the design is adopted, the present application has at least the following advantages:

[0025] The preparation method of the composition for preventing and treating osteoporosis of the present application uses sodium bicarbonate salt roasting and vinegar roasting to process the Eucommia ulmoides Oliv., which can not only destroy the Eucommia ulmoides Oliv. gum, reduce the adhesion of the Eucommia ulmoides Oliv. to the intestinal tract, reduce the wrapping of the effective components by the gum filaments, improve the dissolution of the effective components, but also moderate the warm-dry nature of the Eucommia ulmoides Oliv., which is suitable for people with yin deficiency, and can reduce the side effects of internal heat, such as dry mouth, sore throat, constipation, insomnia and the like, caused by dry heat. In addition, the present application uses Lactobacillus plantarum to ferment Drynaria fortunei, which can decompose naringin in the Drynaria fortunei into naringenin, reduce the astringency of naringin, and metabolize the polysaccharide components in the Drynaria fortunei into small-molecule polysaccharides which are suitable for intestinal absorption, have strong water retention capacity and have lubricating effect on the intestinal tract, and promote intestinal peristalsis, which can significantly reduce the risk of constipation and improve the medication compliance of patients. The composition obtained by the preparation method of the present application not only has the function of preventing osteoporosis of the original composition, but also has the function of reducing the side effects of internal heat, such as constipation, dry mouth, gum swelling and pain or sore throat, and has better long-term efficacy, higher safety and better compliance. DETAILED DESCRIPTION

[0026] The present application will be specifically described below by combining with the examples.

[0027] Example 1

[0028] (1) The raw material of Eucommia ulmoides is crushed, the powder is passed through a 20-mesh sieve, 15 g of sodium bicarbonate is dissolved in 35 ml of water and sprayed onto 750 g of Eucommia ulmoides powder, stirred and sealed for 1 h of soaking, and then slowly fried at 110°C. During the frying process, 150 ml of rice vinegar at 70°C is sprayed, and the frying is stopped after the silk is broken, and the temperature is lowered by spreading. The Eucommia ulmoides extract is obtained by reflux extraction with 70% ethanol for 2 times, with a solid-liquid ratio of 1:10 for the first extraction for 2 h and a solid-liquid ratio of 1:8 for the second extraction for 2 h. After extraction, the filtrate is concentrated, dried, and crushed to obtain the Eucommia ulmoides extract. The slow frying time is 10 min.

[0029] (2) The raw material of Drynaria fortunei is crushed, the powder is passed through an 80-mesh sieve, 670 g of Drynaria fortunei powder is added to a fermentation tank, 270 ml of water is added, and high-temperature sterilization is performed at 100°C for 20 min. After cooling to 35°C, 20 ml of Lactobacillus plantarum is added and mixed uniformly. The temperature is 35°C, and the fermentation is sealed for 3 days. The Drynaria fortunei extract is obtained by reflux extraction with 75% ethanol for 2 times, with a solid-liquid ratio of 1:8 for the first extraction for 2 h and a solid-liquid ratio of 1:6 for the second extraction for 2 h. After extraction, the filtrate is concentrated, dried, and crushed to obtain the Drynaria fortunei extract.

[0030] Among them, the Lactobacillus plantarum is Lactobacillus plantarum ATCC 8014, and the number of viable bacteria is 9×10 8 CFU / ml.

[0031] (3) 80 g of the Eucommia ulmoides extract prepared in the above step, 55 g of the Drynaria fortunei extract, 160 g of D-glucosamine hydrochloride, 80 g of chondroitin sulfate sodium, 50 g of Epimedium extract, 55 g of oyster shell powder, and 115 g of microcrystalline cellulose are mixed uniformly, 95% ethanol is added to make a soft material, 18-mesh sieve is used for granulation, 55-60°C is used for drying, 16-mesh sieve is used for whole granulation, 5 g of magnesium stearate is added, mixed for 30 min, and then compressed into tablets to obtain the composition tablet 1 for preventing and treating osteoporosis. The specification is 0.6 g / tablet.

[0032] Among them, the Epimedium extract is prepared by the existing method, specifically: Epimedium is crushed, 10 times the amount of 70% ethanol is used for reflux extraction for 2 times, each for 1.5 h, the extract is concentrated, and then dried at -0.1 MPa and 80°C, crushed, and passed through an 80-mesh sieve to obtain the Epimedium extract. The content of icariin is 2.5%.

[0033] Example 2

[0034] (1) The raw material of Eucommia ulmoides is crushed, the powder is passed through a 20-mesh sieve, 15 g of sodium bicarbonate is dissolved in 35 ml of water and sprayed onto 750 g of Eucommia ulmoides powder, stirred and sealed for 1 h of soaking, and then slowly fried at 120°C. During the frying process, 150 ml of rice vinegar at 60°C is sprayed, and the frying is stopped after the silk is broken, and the temperature is lowered by spreading and airing. The Eucommia ulmoides extract is obtained by reflux extraction with 70% ethanol for 2 times, with a solid-liquid ratio of 1:10 for the first extraction for 2 h and a solid-liquid ratio of 1:8 for the second extraction for 2 h. After extraction, the filtrate is concentrated, dried, and crushed. The slow frying time is 8 min.

[0035] (2) The raw material of Drynaria fortunei is crushed, the powder is passed through an 80-mesh sieve, 670 g of Drynaria fortunei powder is added to a fermentation tank, 270 ml of water is added, and high-temperature sterilization is performed at 100°C for 20 min. After cooling to 35°C, 20 ml of Lactobacillus plantarum is added and mixed uniformly. The temperature is 35°C, and the fermentation is sealed for 3 days. The Drynaria fortunei extract is obtained by reflux extraction with 75% ethanol for 2 times, with a solid-liquid ratio of 1:8 for the first extraction for 2 h and a solid-liquid ratio of 1:6 for the second extraction for 2 h. After extraction, the filtrate is concentrated, dried, and crushed.

[0036] The Lactobacillus plantarum is Lactobacillus plantarum ATCC 8014, and the number of viable bacteria is 1×10 9 CFU / ml.

[0037] (3) 75 g of the Eucommia ulmoides extract prepared in the above step, 60 g of the Drynaria fortunei extract, 160 g of D-glucosamine hydrochloride, 80 g of chondroitin sulfate sodium, 50 g of Epimedium extract, 55 g of oyster shell powder, and 115 g of microcrystalline cellulose are mixed uniformly, and 95% ethanol is used to make soft material. The granules are prepared using an 18-mesh sieve, dried at 55-60°C, and then sieved using a 16-mesh sieve. 5 g of magnesium stearate is added, mixed for 30 min, and then compressed into tablets to obtain the composition tablet 2 for preventing and treating osteoporosis. The specification is 0.6 g / tablet.

[0038] The Epimedium extract is the same as in Example 1.

[0039] Example 3

[0040] (1) The raw material of Eucommia ulmoides is crushed, the powder is passed through a 20-mesh sieve, 15 g of sodium bicarbonate is dissolved in 35 ml of water and sprayed onto 750 g of Eucommia ulmoides powder, stirred and sealed for 1 h of soaking, and then slowly fried at 100°C. During the frying process, 150 ml of rice vinegar at 80°C is sprayed, and the frying is stopped after the silk is broken, and the temperature is lowered by spreading and airing. The Eucommia ulmoides extract is obtained by reflux extraction with 70% ethanol for 2 times, with a solid-liquid ratio of 1:10 for the first extraction for 2 h and a solid-liquid ratio of 1:8 for the second extraction for 2 h. After extraction, the filtrate is concentrated, dried, and crushed. The slow frying time is 10 min.

[0041] (2) The raw material Gusuibu is crushed, the powder is passed through an 80-mesh sieve, 670 g of Gusuibu powder is added to a fermentation tank, 270 mL of water is added, high-temperature sterilization is performed at 100°C for 20 min, and then the temperature is cooled to 35°C. 20 ml of Lactobacillus plantarum is added and mixed uniformly, sealed fermentation is performed at 35°C for 3 days, 75% ethanol reflux extraction is performed twice, the solid-liquid ratio is 1:8 for the first extraction, extraction is performed for 2 h, the solid-liquid ratio is 1:6 for the second extraction, extraction is performed for 2 h, and then filtration, concentration, drying, and crushing are performed to obtain Gusuibu extract.

[0042] The Lactobacillus plantarum is Lactobacillus plantarum ATCC 8014, and the number of viable bacteria is 9 x 10 8 CFU / ml.

[0043] (3) 85 g of the Eucommia ulmoides extract prepared in the above step, 50 g of the Gusuibu extract, 160 g of D-glucosamine hydrochloride, 80 g of chondroitin sulfate sodium, 50 g of the Epimedium extract, 55 g of oyster shell powder, and 115 g of microcrystalline cellulose are uniformly mixed, soft material is prepared by adding 95% ethanol, granulation is performed on an 18-mesh sieve, drying is performed at 55-60°C, the whole is sieved on a 16-mesh sieve, 5 g of magnesium stearate is added, mixing is performed for 30 min, and then tabletting is performed to obtain an osteoporosis-preventing and treating composition tablet 3. The specification is 0.6 g / tablet.

[0044] The Epimedium extract is the same as in Example 1.

[0045] Example 4

[0046] (1) The raw material Eucommia ulmoides is crushed, the powder is passed through a 20-mesh sieve, 15 g of sodium bicarbonate is dissolved in 35 mL of water and sprayed onto 750 g of Eucommia ulmoides powder, stirring is performed, and then the whole is sealed and soaked for 1 h. Slow frying is performed at 110°C, 150 mL of 70°C rice vinegar is sprayed during the frying process, the frying is stopped after the silk is broken, and then the whole is spread and cooled. 70% ethanol reflux extraction is performed twice, the solid-liquid ratio is 1:10 for the first extraction, extraction is performed for 2 h, the solid-liquid ratio is 1:8 for the second extraction, and the extraction time is 2 h. After extraction, filtration, concentration, drying, and crushing are performed to obtain Eucommia ulmoides extract. The slow frying time is 9 min.

[0047] (2) The raw material Gusuibu is crushed, the powder is passed through an 80-mesh sieve, 670 g of Gusuibu powder is added to a fermentation tank, 270 mL of water is added, high-temperature sterilization is performed at 100°C for 20 min, and then the temperature is cooled to 35°C. 20 ml of Lactobacillus plantarum is added and mixed uniformly, sealed fermentation is performed at 35°C for 3 days, 75% ethanol reflux extraction is performed twice, the solid-liquid ratio is 1:8 for the first extraction, extraction is performed for 2 h, the solid-liquid ratio is 1:6 for the second extraction, extraction is performed for 2 h, and then filtration, concentration, drying, and crushing are performed to obtain Gusuibu extract.

[0048] The Lactobacillus plantarum is Lactobacillus plantarum ATCC 8014, and the number of viable bacteria is 9 x 10 8CFU / ml.

[0049] (3) Take 85 g of the extract of Eucommia ulmoides prepared in the above step, 50 g of the extract of Drynariae Rhizoma, 140 g of D-glucosamine hydrochloride, 100 g of chondroitin sulfate sodium, 50 g of the extract of Herba Epimedii, 55 g of oyster shell powder and 115 g of microcrystalline cellulose, mix them evenly, add 95% ethanol to make soft material, granulate with 18 mesh sieve, dry at 55-60°C, sieve with 16 mesh sieve, add 5 g of magnesium stearate, mix for 30 minutes, and then press into tablets to obtain the composition tablet 4 for preventing and treating osteoporosis. The specification is 0.6 g / tablet.

[0050] The extract of Herba Epimedii is the same as in Example 1.

[0051] Example 5

[0052] (1) The raw material Eucommia ulmoides is crushed, the powder is passed through a 20 mesh sieve, 15 g of sodium bicarbonate is dissolved in 35 ml of water and sprayed onto 750 g of the powder of Eucommia ulmoides, stirred and sealed for 1 h of soaking, and then slowly fried at 110°C. During the frying process, 150 ml of rice vinegar at 70°C is sprayed. After frying to the point of breaking, the fire is turned off and the temperature is lowered by spreading and airing. The Eucommia ulmoides extract is obtained by reflux extraction with 70% ethanol twice, with a solid-liquid ratio of 1:10 for the first extraction for 2 h and a solid-liquid ratio of 1:8 for the second extraction for 2 h. After extraction, filtration, concentration, drying and crushing, the Eucommia ulmoides extract is obtained. The slow frying time is 10 min.

[0053] (2) The raw material Drynariae Rhizoma is crushed, the powder is passed through an 80 mesh sieve, 670 g of the powder of Drynariae Rhizoma is added to a fermentation tank, 270 ml of water is added, high temperature sterilization is performed at 100°C for 20 min, and then cooled to 35°C. 20 ml of Lactobacillus plantarum is added and mixed evenly. The temperature is 35°C, the fermentation is sealed for 3 days, and then extracted twice with 75% ethanol, with a solid-liquid ratio of 1:8 for the first extraction for 2 h and a solid-liquid ratio of 1:6 for the second extraction for 2 h. After extraction, filtration, concentration, drying and crushing, the Drynariae Rhizoma extract is obtained.

[0054] The Lactobacillus plantarum is Lactobacillus plantarum ATCC 8014, and the number of viable bacteria is 9×10 8 CFU / ml.

[0055] (3) Take 85 g of the extract of Eucommia ulmoides prepared in the above step, 50 g of the extract of Drynariae Rhizoma, 150 g of D-glucosamine hydrochloride, 90 g of chondroitin sulfate sodium, 50 g of the extract of Herba Epimedii, 55 g of oyster shell powder and 115 g of microcrystalline cellulose, mix them evenly, add 95% ethanol to make soft material, granulate with 18 mesh sieve, dry at 55-60°C, sieve with 16 mesh sieve, add 5 g of magnesium stearate, mix for 30 minutes, and then press into tablets to obtain the composition tablet 5 for preventing and treating osteoporosis. The specification is 0.6 g / tablet.

[0056] The extract of Herba Epimedii is the same as in Example 1.

[0057] Comparative Example 1

[0058] (1) The raw material Eucommia ulmoides was crushed, and the powder was passed through a 20-mesh sieve. 750 g of the Eucommia ulmoides powder was extracted twice by reflux extraction using 70% ethanol. The solid-liquid ratio was 1:10 for the first extraction, and the extraction was performed for 2 h. The solid-liquid ratio was 1:8 for the second extraction, and the extraction was performed for 2 h. After extraction, the mixture was filtered, concentrated, dried, and crushed to obtain the Eucommia ulmoides extract.

[0059] (2) The raw material Drynaria fortunei was crushed, and the powder was passed through an 80-mesh sieve. 670 g of the Drynaria fortunei powder was added to a fermentation tank, and 270 mL of water was added. The mixture was sterilized at 100°C for 20 min, and then cooled to 35°C. 20 mL of Lactobacillus plantarum was added, and the mixture was uniformly mixed. The mixture was sealed and fermented at 35°C for 3 days. The mixture was extracted twice by reflux extraction using 75% ethanol. The solid-liquid ratio was 1:8 for the first extraction, and the extraction was performed for 2 h. The solid-liquid ratio was 1:6 for the second extraction, and the extraction was performed for 2 h. After extraction, the mixture was filtered, concentrated, dried, and crushed to obtain the Drynaria fortunei extract.

[0060] The Lactobacillus plantarum was Lactobacillus plantarum ATCC 8014, and the number of viable bacteria was 9 x 10 8 CFU / mL.

[0061] (3) 80 g of the Eucommia ulmoides extract prepared in the above step, 55 g of the Drynaria fortunei extract, 160 g of D-glucosamine hydrochloride, 80 g of sodium chondroitin sulfate, 50 g of Epimedium extract, 55 g of oyster shell powder, and 115 g of microcrystalline cellulose were uniformly mixed. The mixture was made into soft material using 95% ethanol, granulated using an 18-mesh sieve, dried at 55-60°C, and granulated using a 16-mesh sieve. 5 g of magnesium stearate was added, and the mixture was mixed for 30 min before being compressed into tablets to obtain the composition tablet 6 for preventing and treating osteoporosis. The specification was 0.6 g / tablet.

[0062] The Epimedium extract was the same as in Example 1.

[0063] Comparative Example 2

[0064] (1) The raw material Eucommia ulmoides was crushed, and the powder was passed through a 20-mesh sieve. 750 g of the Eucommia ulmoides powder was extracted twice by reflux extraction using 70% ethanol. The solid-liquid ratio was 1:10 for the first extraction, and the extraction was performed for 2 h. The solid-liquid ratio was 1:8 for the second extraction, and the extraction was performed for 2 h. After extraction, the mixture was filtered, concentrated, dried, and crushed to obtain the Eucommia ulmoides extract.

[0065] (2) The raw material Drynaria fortunei was crushed, and the powder was passed through an 80-mesh sieve. 670 g of the Drynaria fortunei powder was extracted twice by reflux extraction using 75% ethanol. The solid-liquid ratio was 1:8 for the first extraction, and the extraction was performed for 2 h. The solid-liquid ratio was 1:6 for the second extraction, and the extraction was performed for 2 h. After extraction, the mixture was filtered, concentrated, dried, and crushed to obtain the Drynaria fortunei extract.

[0066] (3) Take 80 g of the extract of Eucommia ulmoides prepared in the above step, 55 g of the extract of Drynariae Rhizoma, 160 g of D-glucosamine hydrochloride, 80 g of chondroitin sulfate sodium, 50 g of the extract of Herba Epimedii, 55 g of oyster shell powder and 115 g of microcrystalline cellulose, mix them evenly, add 95% ethanol to make soft material, sieve granulation with 18 mesh, dry at 55-60°C, sieve the granules with 16 mesh, add 5 g of magnesium stearate, mix for 30 minutes, and then press into tablets to obtain the composition tablet 6 for preventing and treating osteoporosis. The specification is 0.6 g / tablet.

[0067] The extract of Herba Epimedii is the same as in Example 1.

[0068] Comparative Example 3

[0069] (1) The raw material Eucommia ulmoides is crushed, the powder is passed through a 20 mesh sieve, 15 g of sodium bicarbonate is dissolved in 35 ml of water and sprayed onto 750 g of the powder of Eucommia ulmoides, stirred and sealed for 1 h of soaking, and then slowly fried at 110°C until the threads are broken, and then cooled. The powder is extracted twice by refluxing with 70% ethanol, the first extraction is carried out at a solid-liquid ratio of 1:10 for 2 h, and the second extraction is carried out at a solid-liquid ratio of 1:8 for 2 h. After extraction, the filtrate is concentrated, dried and crushed to obtain the extract of Eucommia ulmoides. The time for slow frying is 20 min.

[0070] (2) The raw material Drynariae Rhizoma is crushed, the powder is passed through an 80 mesh sieve, 670 g of the powder of Drynariae Rhizoma is added to a fermentation tank, 270 ml of water is added, high-temperature sterilization is performed, and then the temperature is cooled to 35°C. 20 ml of Lactobacillus plantarum is added and mixed evenly, and then fermentation is carried out at a temperature of 35°C for 3 days. The powder is extracted twice by refluxing with 75% ethanol, the first extraction is carried out at a solid-liquid ratio of 1:8 for 2 h, and the second extraction is carried out at a solid-liquid ratio of 1:6 for 2 h. After extraction, the filtrate is concentrated, dried and crushed to obtain the extract of Drynariae Rhizoma.

[0071] The Lactobacillus plantarum is Lactobacillus plantarum ATCC 8014, and the number of viable bacteria is 9×10 8 CFU / ml.

[0072] (3) Take 80 g of the extract of Eucommia ulmoides prepared in the above step, 55 g of the extract of Drynariae Rhizoma, 160 g of D-glucosamine hydrochloride, 80 g of chondroitin sulfate sodium, 50 g of the extract of Herba Epimedii, 55 g of oyster shell powder and 115 g of microcrystalline cellulose, mix them evenly, add 95% ethanol to make soft material, sieve granulation with 18 mesh, dry at 55-60°C, sieve the granules with 16 mesh, add 5 g of magnesium stearate, mix for 30 minutes, and then press into tablets to obtain the composition tablet 6 for preventing and treating osteoporosis. The specification is 0.6 g / tablet.

[0073] The extract of Herba Epimedii is the same as in Example 1.

[0074] Comparative Example 4

[0075] (1) The raw material of Eucommia ulmoides is crushed, the powder is passed through a 20-mesh sieve, 750 g of Eucommia ulmoides powder is fried at a low fire of 110°C, 150 mL of 70°C rice vinegar is sprayed during the frying process, the frying is stopped after the silk is broken, and the temperature is lowered by spreading and airing. The Eucommia ulmoides extract is obtained by reflux extraction with 70% ethanol for 2 times, the solid-liquid ratio is 1:10 for the first extraction, the extraction time is 2 h, the solid-liquid ratio is 1:8 for the second extraction, the extraction time is 2 h, and then the extract is filtered, concentrated, dried, and crushed. The frying time at a low fire is 30 min.

[0076] (2) The raw material of Drynariae Rhizoma is crushed, the powder is passed through an 80-mesh sieve, 670 g of Drynariae Rhizoma powder is added to a fermentation tank, 270 mL of water is added, high-temperature sterilization is performed at 100°C for 20 min, the temperature is cooled to 35°C, 20 mL of Lactobacillus plantarum is added and uniformly mixed, the temperature is 35°C, and the fermentation is sealed for 3 days. The Drynariae Rhizoma extract is obtained by reflux extraction with 75% ethanol for 2 times, the solid-liquid ratio is 1:8 for the first extraction, the extraction time is 2 h, the solid-liquid ratio is 1:6 for the second extraction, the extraction time is 2 h, and then the extract is filtered, concentrated, dried, and crushed.

[0077] The Lactobacillus plantarum is Lactobacillus plantarum ATCC 8014, and the number of viable bacteria is 9×10 8 CFU / ml.

[0078] (3) 80 g of the Eucommia ulmoides extract prepared in the above step, 55 g of the Drynariae Rhizoma extract, 160 g of D-glucosamine hydrochloride, 80 g of chondroitin sulfate sodium, 50 g of Epimedium extract, 55 g of oyster shell powder, and 115 g of microcrystalline cellulose are uniformly mixed, soft material is prepared by adding 95% ethanol, granulation is performed on an 18-mesh sieve, drying is performed at 55-60°C, the whole is sieved on a 16-mesh sieve, 5 g of magnesium stearate is added, the mixture is mixed for 30 min, and then the tablet is pressed to obtain the composition tablet 9 for preventing and treating osteoporosis. The specification is 0.6 g / tablet.

[0079] The Epimedium extract is the same as in Example 1.

[0080] Comparative Example 5

[0081] (1) The raw material of Eucommia ulmoides is crushed, the powder is passed through a 20-mesh sieve, 15 g of sodium bicarbonate is dissolved in 35 mL of water and sprayed onto 750 g of Eucommia ulmoides powder, the mixture is stirred and sealed for 1 h, and then fried at a low fire of 110°C. 150 mL of 70°C rice vinegar is sprayed during the frying process, the frying is stopped after the silk is broken, and the temperature is lowered by spreading and airing. The Eucommia ulmoides extract is obtained by reflux extraction with 70% ethanol for 2 times, the solid-liquid ratio is 1:10 for the first extraction, the extraction time is 2 h, the solid-liquid ratio is 1:8 for the second extraction, the extraction time is 2 h, and then the extract is filtered, concentrated, dried, and crushed. The frying time at a low fire is 10 min.

[0082] (2) The raw material Drynariae Rhizoma was crushed, and the powder was passed through an 80-mesh sieve. 670 g of the Drynariae Rhizoma powder was extracted twice by reflux extraction using 75% ethanol. The solid-liquid ratio was 1:8 for the first extraction, and the extraction was performed for 2 h. The solid-liquid ratio was 1:6 for the second extraction, and the extraction was performed for 2 h. After the extraction, the mixture was filtered, concentrated, dried, and crushed to obtain the Drynariae Rhizoma extract.

[0083] (3) 80 g of the Eucommiae Cortex extract prepared in the above step, 55 g of the Drynariae Rhizoma extract, 160 g of D-glucosamine hydrochloride, 80 g of chondroitin sulfate sodium, 50 g of the Herba Epimedii extract, 55 g of oyster shell powder, and 115 g of microcrystalline cellulose were uniformly mixed, and the mixture was made into soft material using 95% ethanol. The granules were prepared using a 18-mesh sieve, dried at 55-60°C, and sieved using a 16-mesh sieve. 5 g of magnesium stearate was added, and the mixture was mixed for 30 min before being compressed into tablets to obtain the composition tablet 11 for preventing and treating osteoporosis. The specification was 0.6 g / tablet.

[0084] In the above step, the Herba Epimedii extract was the same as in Example 1.

[0085] Comparative Example 6

[0086] (1) The raw material Eucommiae Cortex was crushed, and the powder was passed through a 20-mesh sieve. 15 g of sodium bicarbonate was dissolved in 35 ml of water and sprayed onto 750 g of the Eucommiae Cortex powder. After stirring, the mixture was sealed and soaked for 1 h. The mixture was slowly fried at 110°C. During the frying process, 150 ml of rice vinegar at 25°C was sprayed. After the mixture was fried until the silk was broken, the fire was turned off, and the mixture was spread and cooled. The mixture was extracted twice by reflux extraction using 70% ethanol. The solid-liquid ratio was 1:10 for the first extraction, and the extraction was performed for 2 h. The solid-liquid ratio was 1:8 for the second extraction, and the extraction was performed for 2 h. After the extraction, the mixture was filtered, concentrated, dried, and crushed to obtain the Eucommiae Cortex extract. The slow frying time was 10 min.

[0087] (2) The raw material Drynariae Rhizoma was crushed, and the powder was passed through an 80-mesh sieve. 670 g of the Drynariae Rhizoma powder was added to a fermentation tank, 270 ml of water was added, and the mixture was sterilized at 100°C for 20 min. After cooling to 35°C, 20 ml of Lactobacillus plantarum was added and uniformly mixed. The mixture was sealed and fermented at 35°C for 3 days. The mixture was extracted twice by reflux extraction using 75% ethanol. The solid-liquid ratio was 1:8 for the first extraction, and the extraction was performed for 2 h. The solid-liquid ratio was 1:6 for the second extraction, and the extraction was performed for 2 h. After the extraction, the mixture was filtered, concentrated, dried, and crushed to obtain the Drynariae Rhizoma extract.

[0088] In the above step, the Lactobacillus plantarum was Lactobacillus plantarum ATCC 8014, and the number of viable bacteria was 9 x 10 8 CFU / ml.

[0089] (3) Take 80 g of the extract of Eucommia ulmoides prepared in the above step, 55 g of the extract of Drynariae Rhizoma, 160 g of D-glucosamine hydrochloride, 80 g of chondroitin sulfate sodium, 50 g of the extract of Herba Epimedii, 55 g of oyster shell powder and 115 g of microcrystalline cellulose, mix them evenly, add 95% ethanol to make soft material, granulate with 18-mesh sieve, dry at 55-60°C, sieve the granules with 16-mesh sieve, add 5 g of magnesium stearate, mix for 30 minutes, and then press into tablets to obtain the composition tablet 1 for preventing and treating osteoporosis. The specification is 0.6 g / tablet.

[0090] The extract of Herba Epimedii is the same as in Example 1.

[0091] Example 1: Detection of the content of effective components in the tablet

[0092] Preparation of the test sample solution:

[0093] Take 4 tablets prepared in the above Examples 1-5 and Comparative Examples 1-6, respectively, and place them in round-bottom flasks. Add 30 mL of methanol to each flask, heat and reflux for 3 h, cool, filter, and transfer the filtrate into a 50 mL volumetric flask. Wash the container with a small amount of methanol for several times, and transfer the washing solution into the same volumetric flask. Add methanol to the mark, and shake well to obtain the test sample solution.

[0094] The test sample solutions prepared in Examples 1-5 and Comparative Examples 1-6 are detected by high performance liquid chromatography, and the contents of the effective components, i.e. icariin, naringin, naringenin, pinoresinol diglucoside, geniposidic acid and aphyllin, in each test sample solution are calculated, respectively. The detection results are shown in Table 1 below.

[0095] Table 1: Detection results of the contents of effective components in each test sample solution

[0096]

[0097] As shown in Table 1, the content of naringenin in the composition tablets obtained in Examples 1-5 is stably maintained at 2.199-2.302 mg / g, while no naringenin is detected in Comparative Example 2 and Comparative Example 5, indicating that the content of naringenin in the extract of Drynariae Rhizoma obtained by direct extraction without fermentation is low, below the detection limit. This result shows that the β-glucosidase produced by Lactobacillus plantarum can indeed promote the deglycosylation of naringin to generate naringenin.

[0098] The content of pinoresinol diglucoside, geniposidic acid and aucubin in the composition tablets obtained in Experimental Example 1-5 is obviously higher than that in Comparative Examples 1-4 and 6, and is equivalent to that in Comparative Example 5, indicating that the processing method of the combination of sodium bicarbonate salt processing and vinegar processing of Eucommia ulmoides Oliv. in the preparation method of the composition can effectively destroy the Eucommia ulmoides Oliv. gum and improve the dissolution of the effective components in Eucommia ulmoides Oliv. Moreover, the content of pinoresinol diglucoside, geniposidic acid and aucubin in the composition tablets obtained in Comparative Examples 3-4 and 6 is lower than that in Experimental Example 5, but is obviously higher than that in Comparative Examples 1-2, indicating that the combination of sodium bicarbonate salt processing and vinegar processing of Eucommia ulmoides Oliv. is obviously superior to the simple sodium bicarbonate salt processing or simple vinegar processing of Eucommia ulmoides Oliv., and the temperature control of vinegar during the vinegar processing has a great influence on the vinegar processing effect.

[0099] Example 2 Animal Experiment

[0100] Materials and grouping:

[0101] 130 SPF level 33-week-old healthy female SD rats with a body weight of 300±20 g were randomly divided into 13 groups, 10 rats in each group. Each group was blank control group, model group, Example 1-5 group, and Comparative Example 1-6 group.

[0102] Animal breeding conditions: barrier system animal house, temperature 20-25℃, relative humidity 40-60%, controlled lighting time 12 / 12 h. One rat per cage, caged feeding, free drinking and eating, timely replacement of bedding, and regular cleaning of the rat cage.

[0103] Establishment of rat yin deficiency and excessive fire type osteoporosis model and drug administration: after 7 days of adaptive feeding, the rats in the model group, Example 1-5 group and Comparative Example 1-6 group were subjected to bilateral ovariectomy operation on the 8th day, and the blank control group was subjected to sham operation. After opening the surgical cavity, suture. Three days after the operation, daily injection of penicillin (400,000 units per rat) was used to prevent infection. The rats were given potassium ascorbate and thyroxine by gavage every day after the operation, wherein the gavage dose of potassium ascorbate was 70 mg / kg, and the gavage dose of thyroxine was 50 μg / kg, for 14 consecutive days, followed by 14 days of gavage of the same volume of normal saline. The blank control group was given normal saline by gavage for 29 consecutive days. Compared with the blank control group, the rats in the model group, Example 1-5 group and Comparative Example 1-6 group had an increase of more than 50% in water consumption, and the bone density detection showed a decrease in bone mass of more than 15%, confirming the success of the rat yin deficiency and excessive fire type osteoporosis modeling.

[0104] One day after the success of the modeling, the tablets of the compositions prepared in Examples 1-5 and Comparative Examples 1-6 were suspended to 36 mg / mL suspension, respectively, and the rats in the groups of Examples 1-5 and Comparative Examples 1-6 were administered by gavage, respectively, with the suspension of the compositions prepared in Examples 1-5 and Comparative Examples 1-6 at a gavage dose of 10 mL / kg once a day for 8 consecutive weeks, and the rats in the blank control group were administered with the same amount of normal saline by gavage.

[0105] After 56 days of continuous gavage, the rats were anesthetized by intraperitoneal injection of sodium pentobarbital at a dose of 45 mg / kg 1 hour after the gavage administration, and blood was taken from the abdominal artery. After the blood was allowed to stand for 20 min, it was centrifuged at a speed of 2000 rpm, and the supernatant was taken and stored in an EP tube at -20°C for standby use.

[0106] (I) Bone density and bone calcium detection

[0107] After the blood was taken, the rats were sacrificed, the left femur was taken, and the bone density (BMD) value of the left hind femur was determined by using a biological X-ray small animal bone density instrument. The femur was dried to constant weight, precisely weighed and recorded, and then ashed and dissolved with acid, and the bone calcium content was determined by EDTA titration. The results are shown in Table 2 below.

[0108] Table 2 Average values of femur bone density, femur dry weight and bone calcium content of rats in each experimental group

[0109]

[0110] As can be seen from the results in Table 2, the femur bone density of the rats in the groups of Examples 1-5 and Comparative Examples 1-6 was significantly different from that of the model group, and the femur bone density of the rats in the group of Examples 1-5 was significantly higher than that in the group of Comparative Examples 1-6.

[0111] The bone calcium content of the rats in the groups of Examples 1-5 and Comparative Examples 1-6 was significantly different from that of the model group. The bone calcium content in the group of Examples 1-5 was higher than that in the group of Comparative Examples 1-6. This indicates that the composition obtained by the preparation method described in Example 1-5 has good ability to improve bone density and bone calcium content.

[0112] (II) Serum detection

[0113] The contents of rat serum bone gla protein (BGP), alkaline phosphatase (ALP), calcitonin (CT), interleukin-1 (IL-1) and interleukin-6 (IL-6) in the serum of the rats in each group were determined by using a fully automatic biochemical analyzer after 8 weeks of gavage administration. The results are shown in Table 3 below.

[0114] Table 3 Content levels of each index in the serum of rats in each experimental group.

[0115]

[0116] From the results of Table 3, it can be seen that the composition tablets of Example 1-5 group and Comparative Example 1-6 group have significant differences in the levels of osteocalcin, alkaline phosphatase and calcitonin in the rat model of yin deficiency and excessive fire type osteoporosis compared with the model group, and are similar to the blank control group. It shows that the composition prepared by the preparation method of Example 1-5 and Comparative Example 1-6 has obvious bone metabolism regulation effect.

[0117] The composition tablets of Example 1-5 group can significantly reduce the content levels of interleukin-1 (IL-1) and interleukin-6 (IL-6) in rat serum compared with the model group, and are better than the composition tablets of Comparative Example 1-6 group. It shows that the composition prepared by the preparation method of Example 1-5 can promote osteoblast differentiation, thereby improving the imbalance of bone metabolism caused by estrogen deficiency.

[0118] (Three) Detection of rat constipation occurrence indicators:

[0119] After the end of intragastric administration of rats on the 49th day, the rat cage bedding and absorbent paper were replaced, and the feces were collected. The feces excreted by rats within 6h were collected.

[0120] The water content of rat feces was detected. After the intragastric administration of rats, the wet weight of feces excreted by rats within 6h was detected by a precision electronic balance, and then placed in an electric heating incubator at 120℃ for 8h. The dry weight of rat feces was detected. Then the water content percentage of rat feces was calculated.

[0121] The water content percentage of rat feces = (wet weight-dry weight) / wet weight x 100%. The results are shown in Table 4 below.

[0122] Table 4 Wet weight, dry weight and water content of rat feces in each experimental group

[0123]

[0124] As can be seen from Table 4, the fecal water content of the rats in the Example 1-5 groups, the model group and the blank control group is 18.48-19.02%, which is within the range of the fecal water content of healthy rats (15-25%). The fecal water content of the rats in the Comparative Example 1 group, the Comparative Example 2 group and the Comparative Example 5 group is 11.83%, 10.45% and 11.29% respectively, which is less than 12% and belongs to constipated rats. In particular, compared with the Comparative Example 2 group which does not perform special processing on Eucommia ulmoides Oliv. and Drynaria fortunei, the control of constipation is particularly significant. The fecal water content of the rats in the Comparative Example 3 group, the Comparative Example 4 group and the Comparative Example 6 group is 12.61%, 14.42% and 12.46% respectively, which belongs to rats with pre-constipation or reduced intestinal peristalsis and has potential constipation risk. It is shown that the composition tablets prepared by the preparation method of Example 1-5 can effectively overcome the adverse reactions such as constipation caused by using the unprocessed original composition, improve the safety and tolerability of the composition, and can significantly enhance the patient's compliance.

[0125] The above description is only the preferred embodiments of the present application, and does not limit the present application in any form. Those skilled in the art can make some simple modifications, equivalent changes or modifications to the disclosed technical contents, which are all within the protection scope of the present application.

Claims

1. A method for preparing a composition for preventing and treating osteoporosis, characterized in that: Includes the following steps: (1) Preparation of Eucommia ulmoides extract: Spray sodium bicarbonate aqueous solution evenly onto Eucommia ulmoides powder, stir and seal to soak for 1 hour, stir-fry at 100-120℃, and spray rice vinegar at 60-80℃ evenly during the stir-frying process. After stir-frying until the fibers break, turn off the heat, spread out to cool down, and extract Eucommia ulmoides twice by reflux with 70% ethanol after cooling. Filter, take the supernatant, concentrate, dry and pulverize to obtain Eucommia ulmoides extract. (2) Preparation of Drynaria fortunei extract: Add Drynaria fortunei powder to a fermenter, add water, sterilize at high temperature, cool and add Lactobacillus plantarum, mix evenly, seal and ferment at 35℃ for 3 days, then extract twice with 75% ethanol under reflux, filter, take the supernatant, concentrate, dry and pulverize to obtain Drynaria fortunei extract. (3) Preparation of composition: Weigh 75-85g of Eucommia ulmoides extract prepared in step (1), 50-60g of Drynaria fortunei extract prepared in step (2), 140-180g of D-glucosamine hydrochloride, 60-100g of chondroitin sulfate sodium, 50g of Epimedium extract and 55g of oyster powder, mix them evenly to obtain the composition for preventing and treating osteoporosis. The preparation method of the epimedium extract is as follows: epimedium is pulverized, extracted twice by reflux with 70% ethanol, the extract is concentrated and dried at -0.1 MPa and 80℃, pulverized and passed through an 80-mesh sieve to obtain epimedium extract.

2. The method for preparing the composition for preventing and treating osteoporosis according to claim 1, characterized in that: In step (1), the Eucommia ulmoides powder is passed through a 20-mesh sieve. The amount of sodium bicarbonate in the sodium bicarbonate aqueous solution is 2% of the weight of the Eucommia ulmoides powder. The volume of the sprayed rice vinegar is 0.2 ml / g of the weight of the Eucommia ulmoides powder. The acetic acid concentration in the rice vinegar is 9%. The simmering time is 8-10 min.

3. The method for preparing the composition for preventing and treating osteoporosis according to claim 2, characterized in that: In step (2), the *Drynaria fortunei* powder is sieved through an 80-mesh sieve, and the volume ratio of water to *Drynaria fortunei* powder is 0.4 ml / g. The high-temperature sterilization conditions are 100℃ for 20 min. The *Lactobacillus plantarum* is *Lactobacillus plantarum* ATCC 8014, and the viable count of the added *Lactobacillus plantarum* is 8 × 10⁻⁶. 8 ~1×10 9 CFU / ml.

4. The method for preparing the composition for preventing and treating osteoporosis according to claim 3, characterized in that: The steps for preparing the composition in step (3) are as follows: Weigh 80g of Eucommia ulmoides extract prepared in step (1), 55g of Drynaria fortunei extract prepared in step (2), 160g of D-glucosamine hydrochloride, 80g of chondroitin sulfate sodium, 50g of Epimedium extract and 55g of oyster powder, mix them evenly to obtain the composition for preventing and treating osteoporosis.

5. A composition for preventing and treating osteoporosis, characterized in that: It is prepared by the method of preparing the composition for preventing and treating osteoporosis according to any one of claims 1 to 4.

6. An oral preparation for the prevention and treatment of osteoporosis, characterized in that: The composition for preventing and treating osteoporosis as described in claim 5, and pharmaceutically acceptable excipients.

7. The oral preparation for preventing and treating osteoporosis according to claim 6, characterized in that: The oral preparation is a tablet, granule, powder, or capsule.

8. The oral preparation for preventing and treating osteoporosis according to claim 7, characterized in that: The oral preparation is a tablet, and the preparation method is as follows: weigh 80g of Eucommia ulmoides extract and 55g of Drynaria fortunei extract, add 160g of D-glucosamine hydrochloride, 80g of chondroitin sulfate sodium, 50g of Epimedium extract, 55g of oyster shell powder and 115g of microcrystalline cellulose, mix evenly, add 95% ethanol to make a soft mass, granulate through an 18-mesh sieve, dry at 55-60℃, granulate through a 16-mesh sieve, add 5g of magnesium stearate, mix for 30 minutes and then compress into tablets to obtain the composition tablet for preventing and treating osteoporosis.

9. The use of the composition for preventing and treating osteoporosis according to claim 5 in the preparation of a drug for preventing and treating osteoporosis.

10. The use of the composition for preventing and treating osteoporosis according to claim 9 in the preparation of a drug for preventing and treating osteoporosis, characterized in that, The composition can reduce the side effect of constipation caused during the prevention and treatment of osteoporosis.

Images